Biosystems
Biosystems appears in FDA public data with 0 recalls, 7 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 9, 2020.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K192730 | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV | September 9, 2020 |
| K190495 | Transferrin | March 16, 2020 |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | May 2, 2019 |
| K170901 | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 | April 13, 2018 |
| K950897 | BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) | August 24, 1995 |
| K950898 | BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE) | August 24, 1995 |
| K950899 | LABORATORY SHARPS BARREL | June 29, 1995 |